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FDA 510(k)

LONE STAR IMPRESSION SYSTEMS

K-Number: K980968 · 1998-06-09

ApplicantLone Star Technologies
Decision Date1998-06-09
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LONE STAR IMPRESSION SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Lone Star Technologies. It received FDA 510(k) clearance on 1998-06-09 under 510(k) number K980968. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LONE STAR IMPRESSION SYSTEMS?

LONE STAR IMPRESSION SYSTEMS is a medical device that received FDA 510(k) clearance on 1998-06-09. The listed applicant is Lone Star Technologies. The 510(k) number is K980968.

When did LONE STAR IMPRESSION SYSTEMS receive FDA 510(k) clearance?

LONE STAR IMPRESSION SYSTEMS received FDA 510(k) clearance on 1998-06-09, under 510(k) number K980968.

Who is the listed applicant for LONE STAR IMPRESSION SYSTEMS?

The FDA 510(k) record lists Lone Star Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LONE STAR IMPRESSION SYSTEMS?

The FDA product code for LONE STAR IMPRESSION SYSTEMS is ELW.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Lone Star Technologies as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K981234FLARE,FILE, FILL

Related Devices (Code: ELW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254152Dia-X Sil Light BodyDiaDent Group InternationalK254142Dia-X Sil Heavy BodyDiaDent Group InternationalK254112Dia-X Sil BiteDiaDent Group InternationalK253501Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set - 454g (1lb) (052327); Chroma Print Premium Fast Set - 454g (1lb) (052457); Chroma Print Premium Regular Set - 454g (1lb) (051460); Perfil Pro - 454g (1lb) (056213); Perfil Pro+ - 454g (1lb) (056121); Perfil Pro Chroma - 454g (1lb) (056122); Hydro Print Premium Fast Set - Multi Pack (056205); Hydro Print Premium Regular Set - Multi Pack (056208); Hydro Print Premium Fast Set - 9,07Kg (20lb) (056204);Vigodent Indústria E Comercio LtdaK250969JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFASTDent4you AGK241924Elastic Impression MaterialBeijing Okvd Biological Technology , Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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